ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL POWERFAST FIZZ- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent 
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ASP Severe Cold Sparkling Original PowerFast Fizz UI1614456

Drug Facts

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*…..………….……..Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg.……………..…...…….....Antihistamine

Phenylephrine bitartrate 7.8 mg …........…………...Nasal decongestant

*nonsteroidal anti-inflammatory drug

Uses

temporarily relieves these symptoms due to a cold:

temporarily reduces fever

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

● hives

● facial swelling

● asthma (wheezing)

● shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

● are age 60 or older

● have had stomach ulcers or bleeding problems

● take a blood thinning (anticoagulant) or steroid drug

● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

● have 3 or more alcoholic drinks every day while using this product

● take more or for a longer time than directed

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use to sedate children.

Do not use

● if you are allergic to aspirin or any other pain reliever/fever reducer

● if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional

conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

● if you have ever had an allergic reaction to this product or any of its ingredients

● in children under 12 years of age

Ask a doctor before use if

● stomach bleeding warning applies to you

● you have a history of stomach problems, such as heartburn

● you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

● you are taking a diuretic

● you have

● asthma

● diabetes

● thyroid disease

● glaucoma

● difficulty in urination due to enlargement of the prostate gland

● a breathing problem such as emphysema or chronic bronchitis

● a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

taking sedatives or tranquilizers

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

taking sedatives or tranquilizers

If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

● adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

● children under 12 years: do not use

Other information
each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

ASP Severe Cold Sparkling Original 24ctAlka-Seltzer Plus®

Severe Cold

Sparkling Original

POWERFAST FIZZ™

NEW LESS RESIDUE

ASPIRIN (NSAID)/Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Phenylephrine Bitartrate/Nasal Decongestant

24 EFFERVESCENT TABLETS

ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL POWERFAST FIZZ 
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorLEMONImprint Code ALKA;SELTZERplus
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0060-0110 in 1 CARTON06/15/2021
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:0280-0060-0218 in 1 CARTON06/15/2021
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:0280-0060-032 in 1 CARTON04/01/2022
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:0280-0060-0412 in 1 CARTON03/30/2023
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:0280-0060-052 in 1 POUCH; Type 0: Not a Combination Product06/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2021
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2023
Document Id: 030bdbcd-d372-5eeb-e063-6294a90ac765
Set id: bd49121c-7cba-c51f-e053-2995a90a921e
Version: 5
Effective Time: 20230816
 
Bayer HealthCare LLC.